Stuttering, Childhood Clinical Trial
Official title:
Integration of Individualized Variables of School-age Children Who Stutter Into Intensive Stuttering Group Therapy and the Effect of Emotional Reactivity on Therapy Outcomes
Verified date | December 2018 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objectives of this investigation were two-fold: 1) to investigate whether
implementation of individualized desensitization exercises in an intensive stuttering group
therapy for school-age children who stutter is superior to the standard application of
intensive stuttering group therapy, 2) to examine the relationship between exhibited
emotional reactivity (positive and negative affect) and stuttering recovery rates. Secondary
objectives included: 1) investigating whether cognitive, affective, linguistic and social
scores differ with treatment and, 2) heart rate and skin conductance changes associated with
the stuttered utterance during intensive stuttering group therapy activities.
Twelve children (8 to 12 years of age, with equal randomization [1:1]) randomized to two
groups; 1) Study group, individualized desensitization exercises implemented in 2 weeks of
intensive stuttering group therapy(n=6), 2) Control group, 2 weeks of standard intensive
stuttering group therapy(n=6). Children were blinded to treatment arm. The first part of this
study was a superiority trial of individualized desensitization exercises in intensive
stuttering group therapy. The second part of the study was conducted with the study group
during the daily therapy activities of intensive stuttering group therapy to investigate the
emotion's effect on therapy outcomes with behavioral and physiological measures.
Status | Completed |
Enrollment | 11 |
Est. completion date | June 20, 2018 |
Est. primary completion date | May 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility |
Inclusion Criteria: - very mild to moderate stuttering based on Stuttering Severity Instrument-4-Turkish Version - no history of intellectual, emotional, academic, hearing, neurological, physiological problems based on parental report - no history of speech and/or language problems other than stuttering - not to be received stuttering therapy during the previous six months. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The stuttering severity | Comparison of control group and study group by Turkish version of Stuttering Severity Instrument-4 score change.Stuttering Severity Instrument-4 is an instrument that measures stuttering severity of children in the age range of 6 to16 years. This instrument measures stuttering severity by 3 sub-items; 1)frequency, 2)duration, and 3)physical concominants. evaluates speech naturalness of the children's speech. Lowest available score on this instrument is 6 and is equivalent to very mild stuttering and 36& higher points are equivalent to very severe stuttering. | One month before therapy to three months after therapy | |
Primary | Emotional reactivity (positive and negative affect) effect on therapy outcome | Obtained by means coding behavioral analysis of positive and negative affect. Emotion facial action coding was used to code positive and negative affects. Positive affect coded when the following action units(AU) appeared; AU 12 (extraction of the lip corner) and AU 6 +12 (cheek up with the extraction of the lip corner). Positive affect may be accompanied by AU1 + 2 (eyebrow elevation), AU25 (mouth opening) or AU 26 (loosening of jaw). If AU12 occurs without AU6, AU12 should occur at least C severity in the intensity classification from 5 to likert type A to E If AU12 is present with AU6, the intensity of AU12 is B. For the acceptance of affect as negative; AU 9 (nose creasing); AU 10 (upper lip elevation); AU 14 (pitting); AU 15 (depression of the lip corner); it is necessary that at least one of the codes AU 20 (lips stretching) and AU 1 + 4 (lifting the eyebrows to the midline and approaching) occur at intensity B. | Collected during first 3 days of the intensive stuttering group therapy to compare the therapy outcomes | |
Secondary | Changes in cognitive, affective, linguistic and social scores | Cognitive, Affective, Linguistic, Motor and Social Rating Scale for School children who stutter is a tool to assess 5 components; 1) cognitive, 2) affective, 3) linguistic, 4) motor, and 5) social. Cognitive component assess the child's awareness, knowledge understanding of stuttering. The affective component gives information on the child's feelings/attitudes related to stuttering & positive/negative attributes of him/her self. The linguistic component assess: overall language, speech sound & vocabulary abilities and, stuttering with regards to the length and complexity of utterances. The social component assess the child's approach to the social situations. At the end every component was rated on a scale of 1-5 (1= low concern, 5= high concern). | One month before therapy to three months after therapy | |
Secondary | Heart rate changes | Obtained via wearable technology. The average of general heart rate values which were expressed in beat per minute was compared with the average heart rate values occurred in one-minute window before and after the stuttered utterances. | Collected during first 3 days of the intensive stuttering group therapy | |
Secondary | Skin conductance changes | Obtained via wearable technology. The average general of skin conductivity values which were expressed in microsiemens was compared with the average skin conductivity values occurred in one-minute window before and after the stuttered utterances. | Collected during first 3 days of the intensive stuttering group therapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05668923 -
Speech Signals in Stuttering
|
N/A | |
Recruiting |
NCT05908123 -
Exploring the Nature, Assessment and Treatment of Stuttering
|
N/A | |
Recruiting |
NCT05003583 -
Effects of Emotional Processes on Speech Motor Control in Early Childhood Stuttering.
|
N/A | |
Completed |
NCT03160586 -
Stuttering and Anxiety
|
N/A | |
Not yet recruiting |
NCT04412213 -
Correlation of Family History, Age at Onset & Severity of Stuttering
|
||
Recruiting |
NCT05286151 -
Network Connectivity and Temporal Processing in Adolescents Who Stutter
|
N/A | |
Not yet recruiting |
NCT05640440 -
Executive Function Performance in Children Who Stutter
|
||
Recruiting |
NCT04929184 -
Speech Processing in Stuttering
|
N/A | |
Not yet recruiting |
NCT05291572 -
Comparative Study Between Three Different Methods for Stuttering Therapy in Children
|
Phase 4 |